Nasopharyngeal Carcinoma
Conditions
Keywords
Nasopharyngeal Carcinoma, Chemoradiotherapy, Accelerated Fractionation
Brief summary
The objectives of this clinical study are threefold: 1. To compare the benefits in cancer control and survival obtained from adding induction-concurrent chemotherapy to radiation with those from adding concurrent-adjuvant chemotherapy to radiation. 2. To test whether replacing fluorouracil with Xeloda in combining with cisplatin in the chemotherapy plan will maintain or improve further the chemotherapy benefits while reducing the duration of hospital stay. 3. To see if accelerated fractionation radiotherapy can improve the outcome of patients as compared with conventional fractionation radiotherapy.
Detailed description
1. primary objectives include 1. comparing induction chemotherapy with Cisplatin + 5-Fluorouracil versus adjuvant chemotherapy with Cisplatin + 5-Fluorouracil(PF-Pvs P-PF) 2. comparing induction chemotherapy with Cisplatin + Capecitabine versus adjuvant chemotherapy with Cisplatin + 5-Fluorouracil(PX-P vs P-PF) 3. comparing accelerated fractionation versus conventional fractionation (AF vs CF)radiotherapy. 2. secondary objectives include 1. comparing induction chemotherapy with Cisplatin + Capecitabine versus induction chemotherapy with Cisplatin + 5-Fluorouracil(PX-P vs PX-P) 2. Comparing concurrent-adjuvant (CA) versus induction-concurrent (IC) chemotherapy sequence.
Interventions
DRUGCapecitabine
Dose:1000 mg/m2, BD, Day 1-Day 14 Interval: 21 days Cycles: 3 cycles
DRUGAdjuvant chemotherapy using PF (5-Fluorouracil )
Cisplatin 80 mg/m2 IV + 5-Fluorouracil 1000 mg/m2/day IV infusion for 96 hr every 28 days for 3 cycles
DRUGInduction chemotherapy using PF (5-Fluorouracil)
Cisplatin 100 mg/m2 IV + 5-Fluorouracil 1000 mg/m2/day IV infusion for 120 hr every 21 days for 3 cycles
Sponsors
The Hong Kong Anti-Cancer Society
hong Kong Cancer Fund
Hong Kong Nasopharyngeal Cancer Study Group Limited
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* histologically proven nasopharyngeal carcinoma for primary treatment with radical intent * non-keratinizing or undifferentiated type * stage III-IVB (by AJCC/UICC 6th edition) * ECOG Performance status less or equal to 2 * Marrow: WBC \>= 4 and platelet \>=100 * Renal: creatinine clearance \>=60 * Informed consent
Exclusion criteria
* Primary treatment with palliative intent * WHO type I squamous cell carcinoma or adenocarcinoma * Evidence of distant metastases * Patient is pregnant or lactating * Prior malignancy except adequately treated basal cell or squamous cell skin cancer, in-situ cervical cancer or other cancer for which the patient has been disease-free for 5 years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-Free Survival, defined as the time to treatment failure at any site or death due to any cause, at 5-year. | 5 years |
| Overall Survival, defined as the time to death due to any cause, at 5-year. | 5 years |
Secondary
| Measure | Time frame |
|---|---|
| Distant Failure-Free Rate, defined as time to distant failure) | 5 years |
| overall Failure-Free Rate, defined as time to failure at any site) | 5 years |
| Time to late toxicity (From the date of randomization to the earliest date of late toxicity grade > 3) | 5 years |
| Incidence of chemotherapy toxicity and acute RT toxicity grade > 3 | treatment |
| Loco-regional Failure-Free Rate, defined as time to local or nodal failure) | 5 years |
Countries
China
Outcome results
None listed